Material Specification & CAPA Specialist – Pharma

Randstad USA; Novato (CA); Hybrid; USD 69,000 - 83,000; Full time

Benefits offered by this job

Medical insurance

401K plan

Job summary

Randstad USA is seeking a Material Sciences Specialist in Novato, CA for a hybrid role (onsite Tuesdays and Wednesdays) to drive a global material specification remediation program supporting regulatory commitments and CAPA activities.

The role requires reviewing raw material specifications against USP, Ph. Eur., JP, and ACS standards, executing change controls, and maintaining tracking dashboards. It offers exposure to regulatory audits in a global pharma setting.

Qualifications

• BS in Chemistry or related field with applicable industry knowledge.
• 3–4 years in pharmaceutical manufacturing, quality, or regulatory roles.
• Hands-on with cGMP docs, change controls, CAPA systems, and technical writing.
• Familiarity with pharmacopeial standards (USP, EP, JP).

Responsibilities

• Review and revise raw material specs against USP, Ph. Eur., JP, and ACS standards.
• Initiate change controls, compile technical justification packages, and track CAPA milestones.
• Maintain spec inventories, update trackers, and generate status dashboards.
• Coordinate with Quality, Regulatory, Supply Chain, and Manufacturing on impact assessments.
• Assemble documentation to ensure inspection readiness for regulatory audits.

Skills

GMP

CAPA

GDP

Education

Bachelor's degree in Chemistry

Tools

Veeva

Job description

Randstad USA is seeking a Material Sciences Specialist in Novato, CA for a hybrid role (onsite Tuesdays and Wednesdays) to drive a global material specification remediation program supporting regulatory commitments and CAPA activities.

The role requires reviewing raw material specifications against USP, Ph. Eur., JP, and ACS standards, executing change controls, and maintaining tracking dashboards. It offers exposure to regulatory audits in a global pharma setting.